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Jobs · Engineering · Indiana

Senior Director, Mechanical & Materials Engineering | Drug Delivery Devices & Combination Products

BioSpace · Indianapolis, IN · 4 days ago
Engineering$164k–$240k/yrFull-time

About the role

Help shape how the world’s leading medicines reach patients. We are seeking a PhD-credentialed engineering leader to own the mechanical design, materials science, and verification testing capabilities behind Lilly’s drug delivery devices and combination products.

Responsibilities

  • Set and own the mechanical and materials technical strategy, aligned with DDCS platform, sustainability, and delivery objectives.

  • Establish and maintain engineering standards, governance, and best practices for mechanical and materials development.

  • Right-First-Time Quality & Execution Excellence

    • Champion a right-the-first-time mindset across the M&M organization, with accountability for reducing deviations and improving execution discipline.
    • Actively monitor deviations and quality signals to identify themes, drive corrective actions, and review progress through established governance forums.
    • Partner closely with Quality, Manufacturing, and Systems teams to proactively manage technical and compliance risk.

  • Capability Transformation & Testing Network Leadership

    • Advance M&M capability improvement initiatives in alignment with established transformation maps, including regular reviews, updates, and progress tracking.
    • Lead and optimize internal and external GMP testing capabilities supporting Design Verification and Stability studies.
    • Establish effective governance and performance metrics with external testing partners.
    • Drive readiness of testing sites, SOP updates, and operational coordination across the testing network.
    • Enable improved scheduling, workload management, and data flow across testing activities.

  • Platform & Portfolio Delivery

    • Grow and expand the platform management initiative across DDCS delivery systems, fostering platform thinking in data, designs, and deliverables.
    • Ensure Mechanical & Materials leadership and support for critical programs, including successful delivery of Boone platform devices through DV, RS, and subsequent phases.
    • Balance near-term execution needs with longer-term platform and capability investments to support the DDCS portfolio.

  • People, Culture & Ways of Working

    • Model and reinforce DDCS @ Work expectations, including safety, inclusion, and effective use of digital tools.
    • Build strong talent pipelines, develop future leaders, and create an inclusive environment where teams can perform at their best.
    • Leverage digital tools and automation to improve efficiency, data integrity, and decision-making across the organization.

Requirements

  • PhD in Mechanical Engineering, Biomedical Engineering, or Materials Science (or a closely related engineering discipline) required.

  • 5+ years of progressive leadership experience in mechanical and/or materials engineering for complex, regulated products.

  • Demonstrated experience leading sizable engineering organizations (on the order of 40 or more people) and large, geographically distributed cross-functional teams.

  • Strong understanding of regulated product development, verification testing, and manufacturing interfaces.

Qualifications

  • Direct experience developing drug delivery devices, injectables, or combination products in a regulated (FDA/ISO 13485) environment.

  • Deep knowledge of materials science, mechanical architectures, and manufacturing processes.

  • Experience managing external testing partners and supplier networks.

  • Strong systems thinking and executive-level communication skills.

  • Proven ability to drive transformation while delivering results.

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